FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
K Number: K252553
·
Decision Oct 9, 2025
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
77
Applicant Total
4
Review Days
57
Basic Information
- Device Name
- Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
- K Number
- K252553
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Jianchao Intelligent Technology Co., Ltd.
- Date Received
- August 13, 2025
- Decision Date
- October 9, 2025
- Product Code
- NFO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | FDA class 2 | Neurology |
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Other Clearances by Shenzhen Jianchao Intelligent Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Jan 30, 2026 | Substantially Equivalent |
| K242710 | Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) | Dec 6, 2024 | Substantially Equivalent |
| K232575 | Hair Removal Device, Model(s): R2815-G Pro, R2815-G | Nov 20, 2023 | Substantially Equivalent |